CMS decision to limit Aduhelm coverage could have ‘ripple effect’ on other potential therapies

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On Tuesday (11 Jan), the CMS released a proposed National Coverage Determination decision memorandum: stating it would cover FDA-approved monoclonal antibodies that target amyloid for the treatment of Alzheimer’s disease solely through coverage with evidence development – meaning it will cover the drug solely for people enrolled in qualifying clinical trials.

Aduhelm is currently the only therapy in this category: but the CMS’s decision is set to apply to similar therapies coming through the pipeline.

The proposal is open to public comment for 30 days, with a final decision to follow by April 11.

“This proposed National Coverage Determination is the result of robust evidence analysis conducted through a thorough review process that found while there may be the potential for promise with this treatment [Aduhelm], there is also the potential for harm to patients. This harm may range from headaches, dizziness, and falls, to other potentially serious complications such as brain bleeds,”​ said Dr. Lee Fleisher, CMS Chief Medical Officer and Director of the Center for Clinical Standards and Quality.

“We believe that any appropriate assessment of patient health outcomes must weigh both harm and benefit before arriving at a final decision. Therefore, based on the public comments submitted previously and evidence CMS reviewed, the potential for harm, and important questions that remain, we have determined that coverage with evidence development through clinical trials is the right decision for Medicare patients, clinicians, and caregivers, and we look forward to receiving feedback on the proposal.”​